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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-004794-10
    Sponsor's Protocol Code Number:A3841047
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2006-004794-10
    A.3Full title of the trial
    A CLUSTER RANDOMIZED TRIAL ON CARDIOVASCULAR RISK FACTOR MANAGEMENT: CADUET® VERSUS USUAL CARE IN SUBJECTS WITH HYPERTENSION AND ADDITIONAL CARDIOVASCULAR RISK FACTORS IN CLINICAL PRACTICE
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA3841047
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Caduet®
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAmlodipine besylate & Atorvastatin calcium
    D.3.9.3Other descriptive nameLI-900003-01
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5/10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Caduet®
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAmlodipine besylate & Atorvastatin calcium
    D.3.9.3Other descriptive nameLI-900003-01
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10/10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HYPERTENSION AND ADDITIONAL CARDIOVASCULAR RISK FACTORS.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10020772
    E.1.2Term Hypertension
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether a Caduet®-based multi-factorial risk factor management strategy might result in greater reduction in total cardiovascular risk as compared with a usual care strategy after one year of treatment in subjects with hypertension and ≥3 additional risk factors, but no CHD and baseline total cholesterol (TC) ≤6.5 mmol/l (250 mg/dl).
    E.2.2Secondary objectives of the trial
    The trial will evaluate a number of secondary endpoints as defined by the protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial at screening and baseline:
    1. Male or female.
    2. Age 35-79 years.
    3. Hypertension: Untreated SBP >160 mmHg and/or DBP >100 mmHg or treated SBP >140 mmHg and/or DBP >90 mmHg (or SBP >130 mmHg and/or DBP >80 mmHg in the presence of diabetes).
    4. Total cholesterol ≤ 6.5 mmol/L (250 mg/dl).
    5. No history of coronary heart disease (CHD).
    6. Three or more cardiovascular risk factors from the following list:
    Smoking
    - Type 2 diabetes
    - Left Ventricular Hypertrophy (LVH) by echocardiography or electrocardiography
    - Peripheral vascular disease
    - ECG abnormalities such as left ventricular strain pattern, Left Bundle Branch Block, ST-T changes compatible with myocardial ischemic heart disease. (ECG evidence of MI would exclude the subject)
    - Family history of early CHD before age 55 in first degree relative
    - History of stroke/ transient ischemic attack (TIA) more than 3 months before screening
    - Age over 55 (men) or 65 (women)
    - Plasma TC/HDL ratio ≥ 6 or HDL below 1mmol/l (below 40mg/dl)
    7. Subject who has signed the informed consent form.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the trial:
    1. Subjects currently receiving statin therapy or stopped statin treatment within 6 months prior to enrollment.
    2. Subjects with untreated SBP ≤ 160 mmHg and DBP ≤ 100 mmHg or treated SBP ≤ 140 mmHg and DBP ≤ 90 mmHg (or SBP ≤ 130 mmHg and DBP ≤ 80 mmHg in the presence of diabetes).
    3. Pregnant or lactating women. Women of childbearing potential who are not using an acceptable method of contraception.
    4. Subjects with a history of myocardial infarction and subjects with a history of coronary artery bypass or intra-coronary interventions.
    5. Subjects with history of atherosclerotic brain infarction, stroke, or transient ischemic attack (TIA) within 3 months.
    6. Subjects with chronic, sustained cardiac arrhythmias (including second or third degree atrioventricular (AV) block, sick sinus syndrome, atrial flutter or any arrhythmias requiring medications), or an accessory bypass track (e.g., Wolff Parkinson White or Lown Ganong Levine syndromes). However, Subjects with chronic, stable atrial fibrillation may be included.
    7. Subjects with congestive heart failure of NYHA Class II, III or IV.
    8. Subjects with secondary dyslipidemia of any etiology, such as nephrotic syndrome or Cushing’s syndrome. Subjects with hypothyroidism may be enrolled if they are on stable doses of thyroid replacement therapy and exhibit normal thyroid stimulating hormone (TSH) levels at baseline.
    9. Subjects with secondary hypertension of any cause, including, but not limited to renal artery stenosis, pheochromocytoma or Cushing’s syndrome.
    10. Diabetic subjects with an elevated glyco-hemoglobin level defined as HbA1c > 9.0% whether treated or not.
    11. Subjects whose arm circumference (for the extremity to be used for the BP measurement) is < 18 cm or > 47 cm (<7 inches or > 19 inches).
    12. A previous history of intolerance or hypersensitivity to the HMG-CoA reductase inhibitors and/or dihydropyridine CCBs, or to drugs with similar chemical structure.
    13. Impaired hepatic function, as shown by but not limited to clinically significant or unexplained elevations of alanine aminotransferase (ALT, SGPT) or aspartate aminotransferase (AST, SGOT) > 2 times the upper limit of normal (ULN) for subjects who are statin-naïve.
    14. An unexplained elevation in CPK (creatine phosphokinase) > 5 times upper limits of normal.
    15. Fasting serum triglyceride concentration of ≥600 mg/dL (8.5 mmol/L).
    16. Abnormal baseline findings considered by the Investigator to be indicative of conditions that might affect study results.
    17. Any other condition, which in the Investigator’s judgment, might result in increased risk to the subject, would interfere with the conduct of the study or interpretation of the data or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
    18. Participation in any other studies involving investigational or marketed products within 1 month prior to entry in the study.
    19. Any condition rendering the subject unable to understand the nature or scope of the study and/or rendering the subject to be unable or unlikely to follow the protocol.
    20. Significant alcohol and/or any other drug abuse within the last year.
    21. Research site personnel.
    22. Subjects on medication that are listed as prohibited medications in section 5.5.
    23. Blood donors who will be giving blood during the study period and for 30 days after the last study visit.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the Month 12 Framingham 10-year risk. This endpoint will be analyzed using a mixed-effects analysis of variance (ANOVA) model. The model will include the baseline Framingham 10-year risk, age, country, gender, and treatment as the fixed effects and site as the random effect. The natural logarithm of the primary endpoint will be the dependent variable and a compound-symmetry (CS) covariance structure will be the covariance matrix for the subjects from the same site. Subjects from different sites will be assumed to be independent. This primary efficacy analysis will produce the following results:
    • The Type III 2-sided p-value of the treatment effect
    • The LS mean (LSM)
    • The 95% confidence interval
    • The estimated ICC
    A statistical superiority of the Caduet® arm over the Usual Care arm will be declared when the 2-sided p-value is less than 0.05.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Usual care of hypertension and additional Cardiovascular risk factors as described by the protocol.
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state96
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 288
    F.4.2.2In the whole clinical trial 1968
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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